MAUDE Adverse Event Report: BIOMET MICROFIXATION 90° CONTRA ANGLE DRIVER; PLATE, BONE

Model Number N/A

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: biomet microfixation ratcheting screwdriver catalog #: 46-0008; lot #: ni.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the driver is stripped.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.On visual inspection, the contra angle driver appears to be in fair overall shape with minor discoloration noted.When rotating the bottom of the driver, there wasn't any significant sticking or resistance noted.An sp-2379 lot# 683420 contra angle driver blade was inserted into the collet and the assembly was functionally tested by attempting to drive a 2.4mm cancellous locking screw into a block of white oak wood.When the screw was driven approximately halfway, the driver was noted to stop functioning and the screw would not advance any further when rotating the gear.The driver was disassembled for further inspection and when disassembling the collet there were metal shavings noted to fall out from the assembly and the teeth of the gear were worn.The dhr was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.The most likely underlying cause of the complaint is the gears experienced force in excess of what they were designed to encounter when driving the screw.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 90° CONTRA ANGLE DRIVER
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8692528
• MDR Text Key: 148314777
• Report Number: 0001032347-2019-00317
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036123130
• UDI-Public: 00841036123130
• Combination Product (y/n): N
• PMA/PMN Number: K121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 24-1189
• Device Lot Number: 555910
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1